[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518423":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":34,"responsibleParty":130,"collaborators":132,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":145,"sex":151,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":10,"studyType":157,"phases":10,"briefSummary":158,"conditions":159,"keywords":10,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Children's Health Ireland","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard",null,"In addition to data from clinical assessment, sleep studies and non-invasive ventilator downloads recorded as part of standard care participants will undergo questionnaire assessment of behaviour, quality of life and barriers to tolerating treatment. Participants aged 3 years and above will receive the Child Sleep Habits Questionnaire, Obstructive Sleep Apnoea-18 questionnaire and Adherence Barriers to CPAP (Continuous Positive Airway Pressure) Questionnaire. Participants aged 6 months to 3 years will receive the Brief Infant Sleep Questionnaire, Infant Toddler Quality of Life - Short Form 47, Obstructive Sleep Apnoea -18 Caregiver Concern Domain and a modified version of the Adherence Barriers to CPAP Questionnaire.",[13],"Device: Non-invasive ventilation",{"label":15,"type":10,"description":16,"interventionNames":17},"Advanced","In addition to all elements of the standard testing group, a sub-group of up to 20 participants will be invited to take part in 45-60 minute semi-structured interviews exploring expectations, experiences and barriers encountered.",[13],[19],{"type":20,"name":21,"description":21,"armGroupLabels":22,"otherNames":10},"DEVICE","Non-invasive ventilation",[15,9],[24],{"name":25,"affiliation":5,"role":26},"Sheila Javadpour","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Roy G 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Maxwell",{"name":87,"role":54,"phone":10,"phoneExt":10,"email":10},"Ruth Harte",{"facility":89,"status":70,"city":90,"state":10,"zip":91,"country":73,"countryCode":74,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Birmingham Children's Hospital","Birmingham","B4 6NH",{"type":43,"coordinates":93},[94,95],-1.89983,52.48142,{"lat":95,"lon":94},[98,100],{"name":99,"role":30,"phone":10,"phoneExt":10,"email":10},"Priti Kenia",{"name":99,"role":26,"phone":10,"phoneExt":10,"email":10},{"facility":102,"status":70,"city":103,"state":10,"zip":104,"country":73,"countryCode":74,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Royal Hospital for Children & Young People","Edinburgh","EH16 4TJ",{"type":43,"coordinates":106},[107,108],-3.19648,55.95206,{"lat":108,"lon":107},[111,113],{"name":112,"role":30,"phone":10,"phoneExt":10,"email":10},"Florian Gahleitner",{"name":112,"role":26,"phone":10,"phoneExt":10,"email":10},{"facility":115,"status":70,"city":116,"state":10,"zip":117,"country":73,"countryCode":74,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Southampton Children's Hospital","Southampton","SO16 6YD",{"type":43,"coordinates":119},[120,121],-1.40428,50.90395,{"lat":121,"lon":120},[124,126,128,129],{"name":125,"role":30,"phone":10,"phoneExt":10,"email":10},"Hazel Evans",{"name":127,"role":30,"phone":10,"phoneExt":10,"email":10},"Catherine M Hill",{"name":125,"role":26,"phone":10,"phoneExt":10,"email":10},{"name":127,"role":26,"phone":10,"phoneExt":10,"email":10},{"type":26,"investigatorFullName":25,"investigatorTitle":131,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Clinical Lead for Respiratory Sleep Medicine",[133,136,137,139,141],{"name":134,"class":135},"University of Edinburgh","OTHER",{"name":89,"class":135},{"name":138,"class":135},"Belfast Health and Social Care Trust",{"name":140,"class":135},"University Hospital Southampton NHS Foundation Trust",{"name":142,"class":135},"University of Dublin, Trinity College","100518423","clinical-outcomes-from-treatment-and-evaluation-of-obstructive-sleep-apnoea-in-children-with-down-syndrome-100518423",false,"NCT06030349","Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome","Real World Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea Syndrome in Children With Down Syndrome","REFRESHED","Inclusion Criteria:\n\n* Individuals with a confirmed diagnosis of Down Syndrome where a clinical decision has been made to initiate respiratory support with non-invasive ventilation.\n* Obstructive Apnoea Hypopnoea Index \\> 2 episodes\u002Fhour or where sleep disordered breathing symptoms occur in combination with an Apnoea Hypopnoea Index \\> 1 episode\u002Fhr. - English language proficiency.\n* Age ≥ 4 months at the commencement of therapy.\n\nExclusion Criteria:\n\n* Individuals not willing to comply with study procedures or assessments.\n* Individuals for whom ventilatory support devices are already prescribed and those with artificial airways.\n* Individuals on clinical trials of investigational support therapies.","ALL","6 Months","16 Years",{"count":155,"type":156},200,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the use of non-invasive ventilation for treatment of obstructive sleep apnoea syndrome in children with Down Syndrome. The main questions it aims to answer are:\n\n* What is the impact of non-invasive ventilation on sleep behaviours and quality of life?\n* What barriers are faced by children and their families in establishing tolerance to non-invasive ventilation?\n\nParticipants will be asked to complete questionnaires before and after starting treatment. Researchers will compare this data with the results of sleep studies and non-invasive ventilator downloads recorded as part of standard medical care. A sub-group of up to 20 participants will be invited to take part in 45-60 minute interviews exploring expectations, experiences and barriers encountered during non-invasive ventilation therapy.",[160,161,162,163,164],"Obstructive Sleep Apnea","Down Syndrome","Quality of Life","Behavior","Adherence, Treatment","2024-02-09",{"date":167,"type":168},"2024-02-12","ACTUAL",{"date":170,"type":168},"2022-11-28",{"date":172,"type":156},"2027-12-28",{"name":5,"class":6},6]